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Premarket Notification Process 510k (US market)

In company Opleiding

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

This course discusses the FDA’s regulatory authority for approving medical devices prior to marketing and the compliance programs used during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections.

Praktisch

In company

Prijs

LEDEN € 630
NIET-LEDEN € 725

KMO-portefeuille: vraag hier uw subsidie aan en bespaar tot 40% op uw inschrijvingsprijs.
Erkenningsnummer Allanta: DV.O105117

 

Word lid

Uw opleiding in detail

Agendapunten

 Introduction to FDA:

  • Classification of devices
  • Premarket Notification 510(k)
  • Premarket Approval (PMA)
  • Establishment registration
  • Medical Device Listing
  • Quality System (QS) regulation
  • Labeling requirements
  • Medical Device Reporting (MDR)
  • Managing FDA inspections at your company

UW LEER-
RESULTATEN

This course gives an overview of the regulations and policies set by the FDA for the pre-market approval, manufacture and post-marketing compliance of medical devices.  The course will provide an understanding of the paths to obtaining agency approval; the type of controls, systems and documentation they expect to see in place; how the FDA performs inspections; and the variety of outcomes from each inspection. 


Uw
certificaat

All students who attend 75% of classes, will receive a certificate of participation.


Uw
docent

Paul Theunissen ondersteunt en begeleidt healthcare providers en Medical Device bedrijven met Regulatory Compliance.

Na het behalen van zijn Masterdiploma Electrical Engineering werkte Paul gedurende 15 jaar in verschillende (Medical) Device ontwikkeling en productie ondernemingen. Initieel als project manager. In deze hoedanigheid voerde hij vele multidisciplinaire ontwikkelingsprojecten uit. In 2004 zette Paul de stap naar quality & regulatory consultancy. Sindsdien faciliteerde Paul vele externe audits en FDA inspecties en lanceerde hij verscheidene producten op de markt. Sinds 2010 is Paul actief als senior consultant voor Allanta vzw.


Uw Contact-
persoon

Nele Gregoor

TEL +32 (0) 11 870 944

info@allanta.be





deelnemer
Materialise
Materialise


Medical Materialise</br> </br> </br>

Hands-on, focus on detail, lots of extra input was given when asked for! Thank you!!  There were numerous posibilities to have discussions on certain topi...

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Daniel
Sanchez
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Medical GSK</br> </br> </br>

"The training was very well organized, the facilities and environment were quite good. I especially liked the format of 6 modules x 3 days, it allows an...

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Laurel
Berzanskis
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Medical Materialise</br> </br> </br>

  I really liked the practical tips for doing an internal audit. Often, people overlook the value of learning the soft skills.

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Sandra
Stam
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Medical Regus Surgical</br></br></br>

Er werd een breed en gevarieerd programma aangeboden. Het publiek was divers, maar er waren zeker en vast interessante topics of cases voor elk individu.

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